Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01974089
Recruitment Status : Completed
First Posted : November 1, 2013
Results First Posted : October 1, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dorte Melgaard Kristiansen, Vendsyssel Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.

The endpoints will be re-hospitalisation and mortality.


Condition or disease Intervention/treatment
Dysphagia Pneumonia Other: Dysphagia

Detailed Description:

Community acquired pneumonia (CAP) is an important cause of morbidity and mortality in elderly patients. Risk factors are many including oropharyngeal dysphagia (OD). Systematic screening of OD is recommended for at-risk popolations, however these resommandations do not specifically address elderly patients hospitalized with CAP.

In this study OD is assessed in all patients by Volume-Viscosity Swallowing Test (V-VST) The study is registered by the Danish Data Protection Authority (2008-58-0028)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia
Study Start Date : October 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Pneumonia and dysphagia
Patients with community aquired pneumonia and oropharyngea dysphagia
 Other: Dysphagia
Oropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test
Pneumonia
Patients with community aquired pneumonia


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Intra Hospital Mortality [ Time Frame: With in 10 days from admission ]
    Intra hospital mortality is death while the patient is hospitalized

  2. 30 Day Mortality [ Time Frame: 30 days after discharge ]
    Death within 30 days of discharge

  3. Re-hospitalization [ Time Frame: 30 days after discharge ]
    The rate of re-hospitalization within 30 days of discharge


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients recruited from the Department of Respiratory Medicine at North Denmeark Regional Hospital.
Criteria

Inclusion Criteria:

  • Temperature > 38 degrees Celcius
  • New infiltrate on chest x-ray
  • Increased C-reactive protein (CRP)
  • Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

Exclusion Criteria:

  • patients referred from the intensive care unit
  • reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974089


Locations
Layout table for location information
Denmark
Vendsyssel Hospital
Hjørring, Denmark, 9800
Sponsors and Collaborators
Vendsyssel Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dorte Melgaard Kristiansen, Developmental therapist, phd, Vendsyssel Hospital
ClinicalTrials.gov Identifier: NCT01974089    
Other Study ID Numbers: RHN_DMK_03
First Posted: November 1, 2013    Key Record Dates
Results First Posted: October 1, 2018
Last Update Posted: April 24, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dorte Melgaard Kristiansen, Vendsyssel Hospital:
Dysphagia
Community acquired pneumonia
Mortality
Rehospitalization
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Deglutition Disorders
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases